Coil fastener applier with flexible shaft

ABSTRACT

A coil fastener applier including a housing, a flexible elongated tubular member, a flexible drive member, a fastener assembly and a trigger is disclosed. The housing defines a longitudinal axis and includes a stationary handle affixed thereto. The flexible elongated tubular portion extends distally from the housing. The flexible drive member is rotatably mounted within the flexible elongated tubular portion. The fastener assembly is mounted adjacent a distal portion of the flexible drive member and is configured to releasably mount at least one coil fastener thereon. The trigger is movably mounted on the housing and movement of the trigger rotates the flexible drive member to drive a coil fastener into tissue. The flexible elongated tubular member and the flexible drive member enable off-axis delivery of a coil fastener.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 11/544,477, filed on Oct. 6, 2006, the entire content of whichbeing incorporated by reference herein.

BACKGROUND

Technical Field

The present disclosure relates to surgical apparatus for fasteningobjects to body tissue and, more particularly, to a coil fastenerapplier having a flexible shaft configured to apply helical coilfasteners to surgical mesh and tissue during surgical repair of the bodytissue in procedures such as hernia repair.

Background of Related Art

Various surgical procedures require instruments capable of applyingfasteners to tissue to form tissue connections or to secure objects totissue. For example, during hernia repair it is often desirable tofasten a mesh to body tissue. In certain hernias, such as direct orindirect inguinal hernias, a part of the intestine protrudes through adefect in the support abdominal wall to form a hernial sac. The defectmay be repaired using an open surgery procedure in which a relativelylarge incision is made and the hernia is closed off outside theabdominal wall by suturing. The mesh is attached with sutures over theopening to provide reinforcement.

Less invasive surgical procedures are currently available to repair ahernia. In laparoscopic procedures surgery is performed in the abdomenthrough a small incision while in endoscopic procedures, surgery isperformed through narrow endoscopic tubes or cannulas inserted throughsmall incisions in the body. Laparoscopic and endoscopic proceduresgenerally require long and narrow instruments capable of reaching deepwithin the body and configured to seal with the incision or tube theyare inserted through. Additionally, the instruments must be capable ofbeing actuated remotely, that is, from outside the body.

Currently endoscopic techniques for hernia repair utilize fasteners,such as, surgical staples or clips, to secure the mesh to the tissue toprovide reinforcement to the repair and structure for encouraging tissueingrowth. The staples or clips need to be compressed against the tissueand mesh to secure the two together.

One other type of fastener suited for use in affixing mesh to tissue,during procedures such as hernia repair, is a coil fastener having ahelically coiled body portion terminating in a tissue penetrating tip.An example of this type of fastener is disclosed in U.S. Pat. No.5,258,000.

Existing coil fastener appliers are often designed for linear andnon-intralumenal use, i.e., they are generally used for affixing mesh toan essentially flat tissue surface via a coil fastener. In certainsituations, it may be desirable to fire surgical fastenersintralumenally. While some surgical instruments (e.g., surgicalstaplers) exist for firing surgical fasteners (e.g., surgical staples)in this manner, the prior art does not include a surgical instrument forfiring a coil fastener within a tube-like organ, such as a colon orintestine, for example. Unlike the firing of surgical staples from asurgical stapler, for example, firing a coil fastener from a coilfastener applier generally requires rotational movement of the coilfastener. A coil fastener applier usable both intralumenally andnon-intralumenally is desired.

SUMMARY

The present disclosure relates to a coil fastener applier including ahousing, a flexible elongated tubular member, a flexible drive member, afastener assembly and a trigger, where the flexible elongated tubularmember and the flexible drive member enable off-axis delivery of a coilfastener. The housing defines a longitudinal axis and includes astationary handle affixed thereto. The flexible elongated tubularportion extends distally from the housing. The flexible drive member isrotatably mounted within the flexible elongated tubular portion. Thefastener assembly is mounted adjacent a distal portion of the flexibledrive member and is configured to releasably mount at least one coilfastener thereon. The trigger is movably mounted on the housing andmovement of the trigger rotates the flexible drive member to drive acoil fastener into tissue.

In an embodiment, the fastener assembly is substantially rigid and isconfigured to releasably mount between about three and about six coilfasteners thereon. In a disclosed embodiment, the length of the fastenerassembly is between about 0.5 inches and about 1.5 inches. It is alsodisclosed that the fastener assembly includes at least one coil fastenerthereon.

In an embodiment, the flexible elongated tubular portion includes alayer of braided steel and a plastic coating disposed about the layer ofbraided steel. In a disclosed embodiment, the flexible drive member ismade essentially of flexible steel.

In a contemplated embodiment, the coil fastener includes an articulationmechanism. The articulation mechanism includes an articulation leverdisposed on a portion of the housing and articulation cables. Thearticulation cables are each operably connected to the articulationlever adjacent their proximal ends and are operably connected to thefastener assembly adjacent their distal ends.

In an embodiment, the coil fastener includes a drive assembly disposedat least partially within the housing. It is disclosed that the driveassembly includes a plurality of gears, at least one of which beingengagable with the flexible drive member for rotating the flexible drivemember. It is also disclosed that the drive assembly includes ananti-reverse mechanism.

The present disclosure also relates to a method of applying coiledfasteners intralumenally. The method includes the steps of providing acoil fastener applier, as described above, providing at least one coilfastener on the fastener assembly, positioning the coil fasteneradjacent an intralumenal tissue site and moving the trigger to cause acoil fastener to be ejected from the coil fastener applier.

DESCRIPTION OF THE DRAWINGS

An embodiment of the presently disclosed handle assembly incorporatingan adjustable force-limiting mechanism is disclosed herein withreference to the drawings, wherein:

FIG. 1 is a perspective view of a coil fastener applier according to anembodiment of the present disclosure;

FIG. 2 is a perspective view of a helical coil fastener utilized withthe coil fastener applier of FIG. 1;

FIG. 3 is a perspective view of a distal portion of a drive rod and ahelical coil fastener;

FIG. 4 is a perspective view of the distal portion of the drive rod witha plurality of helical coil fasteners loaded thereon;

FIG. 5 is a perspective view, with parts separated, of an elongatedtubular portion, a spring and the drive rod with a plurality of helicalcoil fasteners loaded on the distal portion thereof;

FIG. 6 is a sectional view of a distal portion of the elongated tubularportion with the spring installed therein;

FIG. 7 is a perspective view of the elongated tubular portion with thedrive rod inserted therein;

FIG. 8 is a perspective view, with parts separated, of a housing portionof the coil fastener applier of FIG. 1;

FIG. 9 is a perspective view of the housing portion of the coil fastenerapplier of FIG. 1 with the housing half removed;

FIG. 10 is a perspective view of a housing half illustrating thepositioning of the idler gear and the ratchet-plate gear;

FIG. 11 is a perspective view of the assembled idler gear andratchet-plate gear;

FIG. 12 is a sectional view taken along line 12-12 of FIG. 8 andillustrating a roller clutch mechanism;

FIG. 13 is a side view, with a housing half removed, of the housingportion of the coil fastener applier in an initial position;

FIG. 14 is a partial side view, showing the positioning of the idlergear and ratchet-plate gear in an initial position corresponding to FIG.13;

FIG. 15 is a perspective view, partially shown in cross-section, of adistal end portion of the coil fastener applier corresponding to FIG.13;

FIG. 16 is a view similar to FIG. 13 showing initial actuation of thecoil fastener applier;

FIG. 17 is a view similar to FIG. 14 and corresponding to the positionof FIG. 16;

FIG. 18 is a sectional view of the roller clutch corresponding to FIG.16;

FIG. 19 is a perspective view, partially shown in cross-section,illustrating a helical coil fastener being driven out of the distal endof the coil fastener applier;

FIG. 20 is a side view of the housing portion, with a housing halfremoved, illustrating initial release of a trigger and positioning ofthe idler gear and the ratchet-plate gear;

FIG. 21 is a sectional view of the roller clutch corresponding to FIG.20;

FIG. 22 is a partial side view showing the positioning of the idler gearand ratchet-plate gear along with a pawl corresponding to the positionof FIG. 20;

FIG. 23 is a view similar to FIG. 22 after complete release of thetrigger;

FIG. 24 is a perspective view showing the use of the coil fastenerapplier in the patient;

FIG. 25 is a perspective view of a tissue section and a surgical meshsecured to the tissue section by a plurality of helical coil fasteners;

FIG. 26 is a perspective view of an alternate coil fastener;

FIG. 27 is a perspective view of another alternate coil fastener;

FIG. 28 is a perspective view of a coil fastener applier having aflexible shaft, in accordance with an embodiment of the presentdisclosure;

FIG. 29 is a perspective view of a flexible drive member and a fastenerassembly of the coil fastener of FIG. 28, illustrated with coilfasteners on the fastener assembly;

FIG. 30 is a cross-sectional view of a tubular sleeve and the flexibledrive member of the coil fastener of FIGS. 28 and 29; and

FIG. 31 is a plan view of an articulation assembly of the coil fastenerof FIGS. 28-31.

DETAILED DESCRIPTION OF EMBODIMENTS

With reference now to the drawings wherein like numerals represent likeelements throughout the several views and initially with respect to FIG.1, there is disclosed an embodiment of a coil fastener applier 10. Coilfastener applier 10 is provided to apply helical-shaped coil fastenersto tissue or to secure mesh to tissue during surgical procedures such ashernia repair. Coil fastener applier 10 generally includes a housing 12which may be formed as two separate housing halves 12 a and 12 b and ahandle portion 14 extending from housing 12. A trigger 16 is movablymounted to housing 12. Trigger 16 is pivotally connected to housing 12with a free end of trigger 16 spaced from a free end of handle portion14. This arrangement provides an ergonomic advantage and positive securecontrol of trigger 16 and coil fastener applier 10. Coil fastenerapplier 10 also includes an elongated tubular portion 18 extendingdistally from housing 12. The elongated tubular portion 18 is providedto retain a plurality of coil fasteners for application to body tissue.In an embodiment, elongated tubular portion 18 is dimensioned to fitthrough conventional cannula structure. As used herein the term “distal”refers to that portion of the applier, or component thereof, fartherfrom the user while the term “proximal” refers to that portion of theappliers or component thereof, closer to the user.

Referring now to FIG. 2, there is illustrated a helical-shaped coilfastener suitable for use with coil fastener applier 10. Coil fastener20 is designed to be applied to tissue by rotating the coil into andthrough the tissue. Coil fastener 20 generally includes a coil bodyportion 22, illustrated having approximately 2½ coils and terminating ina sharp tissue penetrating point 24. A tang 26 is provided at anopposite end of coil body portion 22. Tang 26 extends generally inwardlytoward the center of coil body portion 22 as shown. Coil fastener 20 maybe formed of a suitable biocompatible material, such as, for example,stainless steel. However, coil fastener 20 may alternatively be formedof various elastomeric or polymeric materials and in addition may beformed of various bioabsorbable or biodegradable materials.

Referring now to FIG. 3, a distal portion 28 of a drive rod 30associated with coil fastener applier 10 is provided to retain and drivecoil fasteners 20. Distal portion 28 generally includes a longitudinallyextending slot 32 extending along the length of distal portion 28. Slot32 is provided to receive tang 26 therein such that upon rotation ofdrive rod 30 coil fastener 20 is similarly rotated. While slot 32 isillustrated as extending partially across drive rod 30, slot 32 may beformed completely through drive rod 30 to accommodate other types ofcoil or rotatable fasteners. A flat 34 extends adjacent slot 32 indistal portion 28.

As best shown in FIG. 4, a plurality of coil fasteners 20 may bearranged in a series longitudinally along the length of distal portion28 of drive rod 30. Each coil fastener 20 has its associated tang 26positioned within slot 32 of drive rod 30.

Referring now to FIG. 5, and as noted above, elongated tubular portion18 contains a plurality of coil fasteners 20 and structure to drive coilfasteners 20 into tissue. A proximal portion 36 of drive rod 30 is of agenerally solid circular cross-section such that slot 32 stops distallyof proximal portion 36. A bent or L-shaped proximal end 38 of drive rod30 is provided to assist in rotating drive rod 30 to advance coilfasteners 20 through elongated tubular portion 18 and drive coilfasteners 20 into tissue. Elongated tubular portion 18 also includes agenerally tubular sleeve 40 defining a bore 42 therethrough and having aproximal end 44 and a distal end 46. Drive rod 30 is freely rotatablewithin bore 42 of tubular sleeve 40.

As best shown in FIGS. 5 and 6, in order to move successive coilfasteners 20 in a distal direction upon rotation of drive rod 30 thereis provided a coiled spring 48 which may be braised or welded to aninner surface 50 of tubular sleeve 40. Coiled spring 48 creates ahelical longitudinally extending surface 52 configured for engagementwith the coil body portions 22 of coil fasteners 20. Thus, upon rotationof drive rod 30 coil fasteners 20 are moved along surface 52 and throughtubular sleeve 40.

As best seen in FIG. 7, when assembled, L-shaped proximal end 38 ofdrive rod 30 extends out of proximal end 44 of tubular sleeve 40 forengagement with a drive assembly described hereinbelow.

Referring now to FIGS. 8 and 9, coil fastener applier 10 is providedwith a hollow bearing 54 having a port 56 formed in one side thereof.Port 56 is provided to receive proximal end 38 of drive rod 30 in orderto rotate drive rod 30 as bearing 54 is rotated. Hollow bearing 54additionally includes a keyed opening 58 formed in a proximal facethereof. A first bevelled gear 62 is provided to rotate bearing 54 andgenerally includes a plurality of teeth 64 and a shaft 66 extendingdistally from teeth 64. First bevelled gear 62 includes a keyed distalend 68 which is configured to securely engage the keyed opening 58 inhollow bearing 54. Thus, upon rotation of first bevelled gear 62 driverod 30 is rotated. As best seen in FIG. 8, first beveled gear 62 isoriented perpendicular to, and rotates about, a longitudinal axis x ofelongated tubular portion 18. A hollow sleeve 70 is provided having aflange 72 which engages slots 74 in housing halves 12 a and 12 b. Sleeve70 rotatably supports first bevelled gear 62 within housing 12.

First bevelled gear 62 forms a part of a drive assembly 76 provided torotate drive rod 30 in a single direction. Drive assembly 76additionally includes a second bevelled gear 78 having a plurality ofteeth 80 configured to engage teeth 64 of first bevelled gear 62. Asshown, first bevelled gear 62 is oriented perpendicularly to secondbevelled gear 78. Thus, second bevelled gear 78 rotates in a planparallel to longitudinal axis x. Second bevelled gear 78 is rotatablysupported within housing 12 by means of a hub 82. A shaft 84 is securedwithin a bore 88 of hub 82. Shaft 84 includes a keyed end 86. A drivegear 90 is provided to rotate the drive assembly 76 and includes a keyedopening 92 for engagement with keyed end 86 of shaft 84. Drive gear 90includes a plurality of teeth 94.

Coil fastener applier 10 additionally includes an actuation assembly 96which, in combination with drive assembly 76, convert longitudinalmotion of trigger 16 into rotary motion of drive rod 30. Actuationassembly 96 generally includes a ratchet-plate gear 98 and an idler gear100, which are rotatably supported on a stud 102 formed in housing half12 a. A compression spring 104 is provided between ratchet-plate gear 98and idler gear 100 in a manner described in more detail hereinbelow. Apair of trigger gears 106 are affixed to ratchet-plate gear 98 on eitherside thereof. It should be noted that trigger gears 106 as well asratchet-plate gear 98, idler gear 100 and drive gear 90 all rotate inplanes parallel to that of second bevelled gear 62 and thus oflongitudinal axis x of elongated tubular portion 18.

As noted hereinabove, trigger 16 is movably mounted on housing 12.Trigger 16 is pivotably mounted about a stud 108 formed in housinghalves 12 a and 12 b. Trigger 16 is provided with a pair of spaced apartgear portions 110 each having a plurality of teeth 112 which cooperateto engage and rotate teeth 114 on trigger gears 106. Thus, by pivotingtrigger 16 about stud 108, gear portions 110 rotate trigger gears 106and thus ratchet-plate gear 98 and idler gear 100. As shown, idler gear100 includes a plurality of teeth 116 on an edge thereof. Teeth 116 areconfigured for engagement with drive gear 90 such that upon actuation oftrigger 16 idler gear 110 is rotated to cause rotation of drive gear 90and thus of drive rod 30. A return spring 118 is provided to biastrigger 16 into an initial position spaced apart from handle 14. Returnspring 118 is affixed at one end to a stud 120 on housing half 12 a andis affixed at an opposite end to a stud 122 on trigger 16.

Actuation assembly 96 additionally includes a ratchet and pawl mechanismwhich prevents return of trigger 16 to an initial position until trigger16 has been fully depressed. Ratchet teeth 124 are shown formed along anedge of ratchet-plate gear 98. A pawl 126 is pivotally mounted about astud 128 on housing half 12 a and is engageable with ratchet teeth 124.Further, a biasing spring 130 is provided to bias pawl 126 intoengagement with ratchet teeth 124. Biasing spring 130 is mounted about astud 132 on housing half 12 a and generally includes a first end 134configured to engage pawl 126 and a second end 136 which is affixedwithin a slot 138 formed in housing 12 a.

Referring now to FIG. 10, structure is provided to prevent more than onecoil fastener 20 from being driven out of coil fastener applier 10 upona single pull of trigger 16. Housing half 12 b includes a blockingmember 140 fixedly mounted to housing half 12 b. Blocking member 140 isconfigured to engage first and second stops 142 and 144, respectively,formed on idler gear 100. Second stop 144 limits the degree of rotationof idler gear 100 during actuation of coil fastener applier 10 toinstall a coil fastener 20 and first stop 142 limits the rotation ofidler gear 100 upon release of trigger 16 enabling coil fastener applier20 to return to an initial position ready to install another coilfastener 20. By providing first and second stops 142 and 144 andblocking member 140, the operator can be assured that drive rod 30 willbe rotated a predetermined number of times and that only a single coilfastener 20 will be driven from coil fastener applier 10 at a singletime.

Turning now to FIGS. 10 and 11, ratchet-plate gear 98 is formed with aslot 146 which is configured to receive a compression spring 104 in afirst portion 150 of slot 146. Compression spring 104 allows a slightamount of rotational movement to occur between ratchet-plate gear 98 andidler gear 100 during actuation and release of trigger 16 in a mannerdescribed in more detail hereinbelow. Idler gear 100 is formed with anengagement tab 152 projecting from a side thereof. Engagement tab 152 ispositionable within a second portion 154 of slot 146. A first edge 156of engagement tab 152 directly engages an edge 148 of ratchet-plate gear98 while a second edge 158 of engagement tab 152 engages compressionspring 104.

Referring now to FIG. 12, coil fastener applier 10 includes anantireverse mechanism which provides for a free return of hub 82independent of second bevelled gear 78. This allows hub 82 to rotatesecond bevelled gear 78 in a driving or first direction when hub 82 isrotated in the first direction to thereby drive coil fastener 20 fromcoil fastener applier 10. The anti-reverse mechanism disengages hub 82from second bevelled gear 78 when hub 82 is rotated in a seconddirection. This is desirable so as to prevent rotation of drive rod 30in a direction opposite that of its driving direction which would rotatecoil fastener 20 such that coil fastener 20 is withdrawn from tissue ormesh or is further withdrawn within tubular portion 18. The anti-reversemechanism is a roller clutch which is formed between hub 82 and secondbevelled gear 78. A plurality of roller pins 160 are provided in acircumferential space or gap 162 defined between hub 82 and secondbevelled gear 78. Gap 162 includes enlarged release areas 164 andreduced grasping areas 166. Thus, as hub 82 is rotated in a firstdirection to move roller pins 160 into the grasping areas 166, rollerpins 160 are cammed within grasping areas 166 to form a solid connectionbetween hub 82 and second bevelled gear 78. Alternatively, when hub 82is rotated in the opposite or second direction, it moves roller pins 160into enlarged release areas 164 allowing hub 82 to rotate freely andindependently of second bevelled gear 78.

The operation of coil fastener applier 10 will now be described.Referring initially to FIG. 13, in an initial or starting position,trigger 16 is biased away from handle 14 due to the force of returnspring 118. As shown, teeth 112 of trigger 16 are engaged with teeth 114of trigger gears 106. Ratchet-plate gear 98 is in a counterclockwisemost position, as viewed in FIG. 13, and pawl 126 is disengaged fromteeth 124 of ratchet-plate gear 98. As best shown in FIG. 14, in theinitial or starting position, blocking member 140 is engaged with firststop 142. In this position, with ratchet-plate gear in itscounterclockwise most position and blocking member 140 engaged withfirst stop 142 of idler gear 100, engagement tab 152 is not engaged withedge 148 of ratchet-plate gear 98 but rather provides a slightcompression to compression spring 104 as shown.

Referring to FIG. 15, within distal end 46 of tubular sleeve 40, aplurality of coil fasteners 20 are slidably mounted about drive rod 30and positioned within tubular sleeve 40. Each coil body portion 22 ofeach coil fastener 20 engages surface 52 of coil spring 48 which, asnoted above, is firmly secured to inner surface 50 of tubular sleeve 40.

Referring now to FIG. 16, to actuate coil fastener applier 10, trigger16 is drawn toward handle 14 against the bias of return spring 118. Astrigger 16 is moved, teeth 112 on gear portions 110 of trigger 16 engageand rotate teeth 114 of trigger gears 106 clockwise as seen in FIG. 16.As shown in FIGS. 16 and 17, rotation of trigger gears 106, rotatesratchet-plate gear 98 such that first edge 156 of engagement tab 152engages ratchet-plate gear 98. Idler gear 100 thus rotates withratchet-plate gear 98 allowing a short expansion of compression spring104. As idler gear 100 is rotated in a clockwise direction, as viewed inFIG. 16, teeth 116 of idler gear 100 engaged and rotate drive gear teeth94 of drive gear 90 counterclockwise.

Referring now for the moment to FIG. 18, as drive gear 90 and thus hub82, are rotated in a counterclockwise direction, the rotation of hub 82causes roller pins 160 to be forced into the reduced grasping areas 166of gap 162. Once moved into grasping areas 166, roller pins 160 form asolid and secure connection between hub 82 and second bevelled gear 78.Thus, second bevelled gear 78 is rotated in a counterclockwise directionas shown in FIGS. 16 and 18. Referring now again to FIG. 16, uponrotation of second bevelled gear 78 in a counterclockwise direction,teeth 80 of second bevelled gear 78 engage teeth 64 of first bevelledgear 62 to thereby rotate drive rod 30 within tubular sleeve 40.

Referring now to FIG. 19, as drive rod 30 is rotated within tubularsleeve 40, drive rod 30 rotates coil fasteners 20. Coil fasteners 20,being engaged with surface 52 of coil spring 48, are moved distallywithin tubular sleeve 40 by engagement of coil body portions 22 withsurface 52. Thus, rotation of drive rod 30 rotates or screws a coilfastener out of the distal end of elongated tubular portion 18. Asshown, this rotation of drive rod 30 also moves a next successive coilfastener 20 into position to be applied to tissue during a next cyclingof coil fastener applier 10.

Referring back to FIG. 16, it should be noted that upon a completedepression of trigger 16, drive rod 30 is rotated precisely apredetermined amount such that only one coil fastener 20 is driven outof the distal end of elongated tubular portion 18. During compression oftrigger 16, pawl 126 engages and rides over teeth 124 of ratchet-plategear 98. Should handle 16 be stopped during depression at anyintermediate position, pawl 126 is engaged with teeth 124 to ensure thatratchet-plate gear 98 and idler gear 100 are not rotated in an oppositedirection thereby preventing only partial insertion or withdrawal ofcoil fastener 20, i.e. preventing a partial drive cycle. As shown inFIG. 16, upon complete depression of trigger 16, pawl 126 passes overteeth 124 and is disengaged therefrom.

Referring to FIG. 17, upon a complete depression of trigger 16, idlergear 100 rotates between a position wherein first stop 142 is rotatedaway from blocking member 140 until a position where blocking member 140engages second stop 144 to thereby prevent further rotation of idlergear 100. This degree of rotation of idler gear 100 corresponds exactlyto the amount of rotation of drive rod 30 necessary to completely drivea single coil fastener 20 out of elongated tubular portion 18 and intotissue.

Referring now to FIG. 20, once trigger 16 had been completely depressedand a coil fastener 20 has been driven from elongated tubular portion 18into tissue mesh or other suitable structure, trigger 16 may bereleased. Trigger 16 is then biased to an open or initial position dueto the force of return spring 118. As trigger 16 is moved to an openposition, teeth 112 of gear portions 110 rotate teeth 114 of triggergears 106 counterclockwise, as viewed in FIG. 20, and thus ratchet-plategear 98 in a counterclockwise direction. As ratchet-plate gear 98 isrotated in a counterclockwise direction, compression spring 104 forcesidler gear 100 also in a counterclockwise direction. With idler gear 100rotating in a counterclockwise direction, teeth 116 of idler gear 100rotate drive gear 90 in a clockwise direction.

Referring now for the moment to FIG. 21, as noted hereinabove, coilfastener applier 10 includes an anti-reverse mechanism or roller clutchwhich disengages drive rod 30 from rotation upon release of trigger 16and allows a free return of drive gear 90 to a start position. Thus,upon clockwise rotation of hub 82, hub 82 moves roller pins 160 into theenlarged release areas 164. Since clutch pins 160 no longer form a solidfirm contact between hub 82 and second bevelled gear 78, hub 82 is freeto rotate independently of second bevelled gear 78 thereby preventingany rotation of drive rod 30.

Referring to FIGS. 20 and 22 and 23, during release of trigger 16, pawl126 moves along teeth 124 of ratchet-plate gear 98 until pawl 126 restson a last tooth 168. This corresponds with the engagement of blockingmember 140 with first stop 142 to thereby prevent any further rotationof idler gear 100. Once pawl 126 has reached its position on last tooth168, the tension of return spring 118, being greater than the force ofcompression spring 104, forces trigger 16 a little further allowingtrigger gears 106 to move ratchet-plate gear 98 slightly against theforce of compression spring 104. As best shown in FIG. 23, the force ofreturn spring 118 overcomes the force of compression spring 104 forcingengagement tab 152 to compress return spring 104. This compression ofreturn spring 118 allows ratchet-plate gear 98 to move slightly enablingpawl 126 to move off of last tooth 168 of ratchet-plate gear 98. Thus,coil fastener apparatus 10 is returned to initial position ready to beactuated again and install another coil fastener.

Referring now to FIG. 24, coil fastener applier 10 is shown positionedthrough a small incision A made in a patient B for use in a surgicalprocedure, such as, for example, hernia repair.

Referring now to FIG. 25, when used for hernia repair, surgical coilfastener applier 10 may be utilized to affix a portion of a suture mesh170 to a tissue section 172. As shown in FIG. 25, several coil fasteners20 may be utilized to secure mesh 170 to tissue 172. It is disclosedthat, in applying coil fasteners 20, coil fasteners 20 are rotatedthrough mesh 170 and tissue 172 such that only approximately 180 degreesof coil body portion 22 along with tang 26 extend externally of the mesh170. Tang 26 provides an anchoring or securing mechanism to prevent mesh170 from sliding off of coil body portion 22 of coil fastener 20.

Referring now to FIGS. 26 and 27, there are disclosed alternateembodiments of coil fasteners suitable for use with coil fastenerapplier 10. Referring first to FIG. 26, an alternate embodiment coilfastener 174 is formed with a straight backspan 176 and helical coilbody portions 178, 180 extending from each end of back span 176. Tissuepenetrating points 182, 184 is provided at a free end of respective bodyportions 178, 180. Backspan 176 engages a slot extending completelythrough a drive rod (not shown) and is slidably supported thereon.Rotation of the drive rod rotates coil fastener 174 within sleeve 40 ofcoil fastener applier 10 and into tissue.

Referring now to FIG. 27, in a further alternative embodiment, a coilfastener 186 is formed with a straight backspan 188 having straight legs190, 192 extending from each end of backspan 188 and which are parallelto each other. Semi-circular tissue penetrating portions 194, 196terminating in tissue penetrating points 198, 200 extend from a free endof respective leg 190, 192. Semi-circular tissue penetrating portions194, 196 are located in a common plane which is generally parallel tobackspan 188. The backspan of the coil fastener also engages acompletely slotted drive rod (not shown) and is rotated thereby.

Referring now to FIGS. 28-31, a coil fastener applier 310 having aflexible elongated tubular portion 320 is shown. Coil fastener applier310 includes a housing 312, a flexible elongated tubular portion 320, aflexible drive member 330, a fastener assembly 340 and a trigger 316.Housing 312 defines a longitudinal axis A-A (FIG. 28) and includes astationary handle 315 affixed thereto. Flexible elongated tubularportion 320 extends distally from housing 312. Flexible drive member 330is rotatably mounted within flexible elongated tubular portion 320.Fastener assembly 340 is mounted adjacent a distal portion 332 (FIG. 29)of flexible drive member 330. Fastener assembly 340 is configured toreleasably mount at least one coil fastener 174 (FIG. 29) thereon.Trigger 316 is movably mounted on housing 312 and movement of trigger316 rotates flexible drive member 330 to drive coil fastener 174 intotissue (e.g., a colon or intestine), not explicitly shown in thisembodiment. Flexible elongated tubular portion 320 and flexible drivemember 330 enable off-axis (i.e., not along or parallel to axis A-A)delivery of a coil fastener 174. That is, coil fastener 174 may bedelivered in any reasonable direction intersecting axis A-A at an angle∀ (including all reasonable angles with respect to the x-, y- andz-axes), such as in the direction illustrated by arrow B in FIG. 28.

Referring to FIG. 29, the illustrated embodiment of flexible drivemember 330 includes a bent or L-shaped member 338 at its proximal end334 and is mounted to fastener assembly 340 at its distal end. It isenvisioned that flexible drive member 330 is connected to L-shapedmember 338 and to fastener assembly 340 via braising. L-shaped member338 mechanical cooperates with a drive assembly 76 (see FIG. 8) tofacilitate rotation of flexible drive member 330, as described abovewith respect to drive rod 30.

Fastener assembly 340 is illustrated in FIG. 29 as a substantially rigidmember that is configured to releasably mount at least one coil fastener174. In FIG. 28, fastener assembly is hidden from view behind a distalportion 326 of flexible elongated tubular portion 320. In the embodimentshown in FIG. 29, four coil fasters 174 are illustrated mounted onfastener assembly 340. It is envisioned that any reasonable number ofcoil fasteners 174 are mounted or mountable to fastener assembly 340,including between about three and about six coil fasteners 174. As shownin FIG. 28, the length of fastener assembly 340 in relation to the totallength of flexible elongated tubular portion 320 is relatively short.The rigidity of fastener assembly 340 allows coil fasteners 176 to bemounted thereon and fired therefrom, but its short length enables amajority of the length of coil fastener applier 310 (i.e., flexibleelongated tubular portion 320) to follows a curvilinear path of atubular organ. In an embodiment, the length L of fastener assembly 340is between about 0.5 inches and about 1.5 inches and is moreparticularly between about 0.75 inches and about 1.0 inches.

Referring to FIG. 30, a cross-section of flexible elongated tubularportion 320 and flexible drive member 330 is shown. Flexible elongatedtubular portion 320 includes a first layer 322 and a second layer 324.In an embodiment, first layer 322 includes a braided steel material thatenables flexible elongated tubular portion 320 to flex along its length.It is disclosed that second layer 324 includes a plastic coatingsurrounding first layer 322. Such a plastic coating may protect firstlayer 322, facilitate motion through a body part, and enables flexibleelongated tubular portion 320 to maintain its flexibility. Flexibleelongated tubular member 330 is illustrated about flexible drive member330. Flexible drive member 330 or cable is made of a material thatenables its flexibility and is substantially rigid enough to be rotatedalong its (possibly) curved length. One material that flexible drivemember 330 may be made from is flexible steel.

The flexible qualities of flexible elongated tubular member 320 andflexible drive member 300 facilitate the guiding of fastener assembly340 within a body lumen. In an embodiment, at least distal portion 326of flexible elongated tubular portion 320 is inserted into a lumen (notexplicitly shown in this embodiment). Housing 312 is then pusheddistally to advance flexible elongated tubular portion 320 through thelumen. Flexible elongated tubular portion 320 is able to be guidedand/or steered through the lumen by having the ability to flex/bendalong its length to at least somewhat conform to any convolutions of thelumen. Flexible elongated tubular portion 320 (and flexible drive member330) are rigid enough to advance through material/fluid within a lumenand are also flexible enough to curve/bend when a portion of flexibleelongated tubular portion 320, e.g., distal portion 326, contacts aninternal wall of the lumen.

Referring to FIG. 31, an articulation mechanism 350 is illustrated.Articulation mechanism 350 may facilitate the intralumenal positioningof a portion of coil fastener applier 310, e.g., fastener assembly 340.In the illustrated embodiment, articulation mechanism 350 includes apair of articulation cables 352 a, 352 b and an articulation lever 360(or other suitable structure) pivotally mounted on housing 312 (FIG.28). Articulation cables 352 a, 352 b are each operably connected (e.g.,braised) to fastener assembly 340 adjacent their distal ends 354. Eacharticulation cable 352 a, 352 b is operably connected to articulationlever 360, e.g., via an articulation link 358, adjacent their proximalends 356. Pivotal movement of articulation lever 360 causes articulationcables 352 a, 352 b to move in opposite directions and thus causesfastener assembly 340 to articulate relative to housing 312. Forexample, movement of articulation lever 360 may cause articulation link358 to move about pivot 359 in the direction of arrow C, thus pullingarticulation cable 352 a proximally. This movement also pushesarticulation cable 352 b distally in the direction of arrow D and causesfastener assembly 340 to articulate in the general direction of arrow E.

Articulation cables 352 a, 352 b are illustrated being operablyconnected to a proximal portion of fastener assembly 340 and withinflexible elongated tubular portion 320 (not shown in FIG. 31). Inanother embodiment of the present disclosure, articulation cables 352 a,352 b may extend along an outer perimeter of flexible elongated tubularportion 320 (e.g., between first layer 322 and second layer 324 orexternal of second layer 324) and may be operably connected adjacentdistal portion 326 of flexible elongated tubular portion 320 (notexplicitly shown in this embodiment).

The present disclosure also relates to a method of applying coiledfasteners 174 intralumenally. The method includes providing coilfastener applier 310, as described above, providing at least one coilfastener 174 on fastener assembly 340, positioning coil fastener applier310 adjacent an intralumenal tissue site and moving trigger 316 to causecoil fastener 174 to be ejected from coil fastener applier 310.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, a shorter elongated tubularportion containing more or less coil fasteners may be provided forgreater ease of handling during open surgery. Various articulations maybe provided along the length of the elongated tubular portion tofacilitate positioning of the coil fastener applier within the body.Additionally various configurations of the drive rod and slots orfastener retaining structure may be provided to accommodate varioustypes of rotary fasteners. Therefore, the above description should notbe construed as limiting, but merely as exemplifications of variousembodiments. Those skilled in the art will envision other modificationswithin the scope and spirit of the claims appended hereto.

The invention claimed is:
 1. A coil fastener applier, comprising: ahousing; a flexible elongated tubular portion extending distally fromthe housing; a flexible drive member rotatably mounted at leastpartially within the flexible elongated tubular portion; and a fastenerassembly connected to a distal portion of the flexible drive member, thefastener assembly configured to releasably mount at least one coilfastener thereon, wherein the flexible elongated tubular portion and theflexible drive member enable off-axis delivery of at least one coilfastener.
 2. The coil fastener applier of claim 1, wherein the fastenerassembly is substantially rigid.
 3. The coil fastener applier of claim1, wherein the fastener assembly is configured to releasably mountbetween about three and about six coil fasteners thereon.
 4. The coilfastener applier of claim 1, wherein a length of the fastener assemblyis between about 0.5 inches and about 1.5 inches.
 5. The coil fastenerapplier of claim 1, wherein the flexible elongated tubular portionincludes a layer of braided steel.
 6. The coil fastener applier of claim5, wherein the flexible elongated tubular portion includes a plasticcoating disposed about the layer of braided steel.
 7. The coil fastenerapplier of claim 1, wherein the flexible drive member is madeessentially of flexible steel.
 8. The coil fastener applier of claim 1,further including an articulation mechanism including an articulationlever and articulation cables, the articulation lever disposed on aportion of the housing, the articulation cables operably connected tothe articulation lever adjacent their proximal ends and operablyconnected to the fastener assembly adjacent their distal ends.
 9. Thecoil fastener applier of claim 1, further including a drive assemblydisposed at least partially within the housing.
 10. The coil fastenerapplier of claim 9, wherein the drive assembly includes gears, at leastone of the gears engagable with the flexible drive member for rotatingthe flexible drive member.
 11. The coil fastener applier of claim 9,wherein the drive assembly includes an anti-reverse mechanism.
 12. Thecoil fastener applier of claim 1, wherein the fastener assembly includesat least one coil fastener mounted thereon.
 13. A method of applying acoil fastener, comprising: providing a coil fastener applier, including:a housing defining a first axis; a flexible elongated tubular portionextending distally from the housing; a flexible drive member rotatablymounted at least partially within the flexible elongated tubularportion; and a fastener assembly connected to a distal portion of theflexible drive member, the fastener assembly configured to releasablymount at least one coil fastener thereon; positioning at least one coilfastener on the fastener assembly; and delivering the at least one coilfastener along a second axis, the second axis offset from the firstaxis.
 14. The method of claim 13, wherein positioning at least one coilfastener on the fastener assembly includes positioning between aboutthree and about six coil fasteners on the fastener assembly.
 15. Themethod of claim 13, further comprising articulating the fastenerassembly with respect to the housing.
 16. The method of claim 13,further comprising rotating the fastener assembly with respect to thehousing.
 17. The method of claim 13, wherein delivering the at least onecoil fastener along the second axis includes the first axis defining anacute angle with respect to the second axis.